The ICONN Answer II Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. Specific indications are as follows: Shoulder Indications: Rotator Cuff Repairs, Biceps Tenodesis Foot/Ankle Indications: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Device Description

The ICONN Answer II Suture Anchor (P/N's 147501 and 155001) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-600L polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in two sizes (Diameter x Length): 4.75mm x 16mm and 5.5mm x 16mm.

AI/ML Overview

The provided text is a 510(k) summary for the ICONN Answer II Suture Anchor, a medical device. It describes performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about studies involving AI or human readers for diagnostic purposes.

Therefore, I cannot fulfill your request for information related to:

A study proving the device meets acceptance criteria using an AI system.
Number of experts establishing ground truth or their qualifications.
Adjudication method.
MRMC comparative effectiveness study.
Standalone algorithm performance.
Sample size and ground truth for training set.

The document focuses on mechanical and biocompatibility testing for a physical medical device (suture anchor), not a diagnostic AI system.

Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and performance, as appropriate for a physical implantable device:

Description of Device Testing and Acceptance Criteria

The ICONN Answer II Suture Anchor underwent performance testing to demonstrate its safety and effectiveness, and substantial equivalence to its predicate device (Arthrex PEEK Corkscrew FT (K061665)). The tests focused on mechanical properties, biocompatibility, and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Specific Test / Parameter	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Anchor displacement after cyclic loading	Performance similar or better than predicate, or within acceptable ranges. (Guidance from FDA's Draft Guidance Document for Testing Bone Anchor Devices, April 20, 1996)	Performed similarly or better than the predicates or within acceptable ranges for the intended use.
	Ultimate anchor pull-out	Performance similar or better than predicate, or within acceptable ranges. (Guidance from FDA's Draft Guidance Document for Testing Bone Anchor Devices, April 20, 1996)	Performed similarly or better than the predicates or within acceptable ranges for the intended use.
	Torsional properties (Insertion Testing)	Demonstrate device can be safely implanted. (Followed ASTM F543-2013, section A1)	Analyzed and compared to demonstrate the device can be safely implanted.
	Driving torque (Insertion Testing)	Demonstrate device can be safely implanted. (Followed ASTM F543-2013, section A2)	Analyzed and compared to demonstrate the device can be safely implanted.
Biocompatibility Testing	Cytotoxicity	Cytotoxicity score of 2 or less (in accordance with ISO 10993/(R)2013).	All test articles resulted in a cytotoxicity score of zero (0).
	Irritation (SC extract)	Score difference of 0.2 or less (in accordance with ISO 10993/(R)2013).	Score difference of 0.0.
	Irritation (SO extract)	Score difference of 0.2 or less (in accordance with ISO 10993/(R)2013).	Score difference of 0.1.
	Sensitization	No evidence of causing delayed dermal contact sensitization (in accordance with ISO 10993/(R)2013).	No evidence of causing delayed dermal contact sensitization.
	LAL testing (Endotoxin)	< 20 EU/device (in accordance with ANSI/AAMI ST72:2016).	The test articles were <0.05 EU/device.
	Material-mediated Pyrogenicity	Non-pyrogenic.	Determined to be non-pyrogenic.
Sterilization Validation	Bioburden Recovery	Used as an adjustment factor; no specific acceptance criteria stated for this test itself.	51.5% (used as an adjustment factor for bioburden data).
	Bioburden (3 Lots)	< 1,000 CFU/device.	<3.9 CFU/device for all three lots.
	Bacteriostasis/Fungistasis (B/F)	Demonstrates no inhibition from test article; all challenge organisms show positive growth on both subject device and control.	Demonstrated no inhibition from the test article with all three challenge organisms showing positive growth on both subject device and control samples.
	Sterility	Not more than one (1) positive test of sterility.	Zero (0) positive tests of sterility.

2. Sample size used for the test set and the data provenance:

The document mentions "side by side mechanical testing performed on the subject device and predicate" and "Bioburden – 3 Lots," but does not explicitly state the number of samples or devices tested for each mechanical or biocompatibility test. The data provenance is not explicitly stated as retrospective or prospective, but testing for device clearance typically occurs prospectively as part of product development. The country of origin of the data is implied to be within the US, given the FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical implant, and the "ground truth" for mechanical and biocompatibility testing is based on objective laboratory measurements and established biological assays, not expert interpretation of diagnostic images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This concept is relevant for studies involving human interpretation or consensus, such as clinical trials or AI performance evaluations, not for basic device performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to a physical suture anchor, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This document pertains to a physical suture anchor, not an algorithm.

7. The type of ground truth used:

Mechanical Testing: Objective measurements (e.g., force, displacement, torque) against established engineering standards (e.g., FDA Draft Guidance, ASTM F543-2013). The "ground truth" is the physical behavior of the device under defined conditions.
Biocompatibility Testing: Results of standardized biological assays (e.g., ISO 10993) against predefined acceptance criteria for cellular response, irritation, sensitization, and endotoxin levels. The "ground truth" is the biological reaction to the material.
Sterilization Validation: Microbiological testing results against established sterility assurance levels and bioburden limits. The "ground truth" is the confirmed absence of viable microorganisms.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning study.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/machine learning study.

Summary

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ICONN Orthopedics, LLC Whitt Israel CEO 400 Union Hill Drive, Suite 150 Birmingham, Alabama 35209

Re: K181680

Trade/Device Name: ICONN Answer II Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 22, 2018 Received: June 26, 2018

Dear Whitt Israel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

August 9. 2018

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) TBD

Device Name ICONN Answer II Suture Anchor

Indications for Use (Describe)

The ICONN Answer II Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. Specific indications are as follows:

Shoulder Indications: Rotator Cuff Repairs, Biceps Tenodesis

Foot/Ankle Indications: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "ICONN ORTHOPEDICS". The word "ICONN" is written in a sans-serif font, with the two "N"s in gray and the "O" represented by a blue circle. The word "ORTHOPEDICS" is written in a smaller font below the word "ICONN".

400 Union Hill Drive, Suite 150 Birmingham, AL 35209

510(k) SUMMARY

Submitter's Name:	ICONN Orthopedics, LLC
Submitter's Address:	400 Union Hill DriveSuite 150Birmingham, AL 35209
Submitter Contact Person:	Whitt IsraelCEO(205) 913-2068
Date Summary was Prepared:	June 22, 2018
Trade Name or Proprietary Name:	ICONN Answer II Suture Anchor
FDA Submission Document Number:	K181680
Common or Usual Name:	Suture Anchor
Classification:	Class II per 21 CFR §888.3040
Product Code:	MBI - Fastener, Fixation, Nondegradable, Soft Tissue
Classification Panel:	Division of Orthopedic Devices
TechnologicalCharacteristics:	The ICONN Answer II Suture Anchor System suture anchorsare of similar design to the predicate and are manufactured withthe same basic material in similar sizes.
Performance Data:	Performance testing was conducted for both pulloutcharacteristics and torsional properties. For pulloutcharacteristics, the FDA's Draft Guidance Document for TestingBone Anchor Devices (April 20, 1996) was used for guidance inside by side mechanical testing performed on the subject deviceand predicate for the following test modes:
	● Anchor displacement after cyclic loading● Ultimate anchor pull-out
	Pullout testing showed that the ICONN Answer II Suture Anchorperformed similarly or better than the predicates or withinacceptable ranges for the intended use. For insertion testing,ASTM F543-2013 was followed, specifically the sections ontorsional properties (section A1 of the standard) and driving torque(section A2 of the standard) were analyzed and compared todemonstrate the device can be safely implanted.
	Cytotoxicity, irritation, and sensitization testing were carried out inaccordance with ISO 10993/(R)2013 and all testing metacceptance criteria. For cytotoxicity, all test articles resulted in acytotoxicity score of zero (0) with an acceptance criteria of 2 orless. For irritation, a score difference of 0.0 for the SC extract and0.1 for the SO extract was seen, with an acceptance criteria of 0.2or less. For sensitization, the test article extracts showed noevidence of causing delayed dermal contact sensitization, which isalso the acceptance criteria.
	In accordance with ANSI/AAMI ST72:2016 LAL testing wasconducted using the Kinetic-Chromogenic assay and the resultsdemonstrated the test articles were <0.05 EU/device, which metacceptance criteria of < 20 EU/device. Material-mediatedpyrogenicity testing was conducted and the device wasdetermined to be non-pyrogenic.
	Sterilization validation testing (Bioburden Recovery, Bioburden – 3Lots, Bacteriostasis/Fungistasis, and Sterility) was carried out andmet acceptance criteria. Bioburden Recovery was 51.5% (usedas an adjustment factor for bioburden data, so no acceptancecriteria were required for this test). Bioburden testing resulted in<3.9 CFU/device for all three lots, which met acceptance criteria of<1,000 CFU/device. B/F results demonstrated no inhibition fromthe test article with all three challenge organisms showing positivegrowth on both subject device and control samples. This met theacceptance criteria of showing no inhibition. Sterility testing

Device Description:	The ICONN Answer II Suture Anchor (P/N's 147501 and 155001)is a sterile (gamma irradiation), single use implantable devicemade from Solvay's Zeniva® ZA-600L polyetheretherketone(PEEK) material indicated for soft tissue reattachment proceduresin the shoulder, foot, and ankle. The anchor is available in twosizes (Diameter x Length): 4.75mm x 16mm and 5.5mm x 16mm.
Intended Use:	The ICONN Answer II Suture Anchor is indicated for soft tissuereattachment procedures in the shoulder, foot, and ankle. Specificindications are as follows:
	Shoulder Indications : Rotator Cuff Repairs, Biceps Tenodesis.
	Foot/Ankle Indications : Lateral Stabilization, Medial Stabilization,Achilles Tendon Repair, Hallux Valgus Reconstruction, MidfootReconstruction, Metatarsal Ligament Repair.
Predicate Device:	The predicate device was selected to help demonstratesubstantial equivalence of several characteristics to includeintended use, design, sizes, PEEK material, supplying the devicein the sterile state, and provision of sutures. The predicate deviceis listed below:
	• Arthrex PEEK Corkscrew FT (K061665)

Arthrex PEEK Corkscrew FT (K061665) .

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resulted in zero (0) positive tests of sterility which met acceptance criteria of not more than one (1) positive test of sterility. Conclusion: The submitted device has been demonstrated to be as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

N/A